MAUDE Adverse Event Report: CODMAN 3000 PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Device Problem Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 04/30/2017

Event Type  Injury  

Manufacturer Narrative

Unknown product code, udi unavailable.It is not clear at this point if the device and/or lot information is available.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If the device is returned the complaint will be investigated and a follow up report will be filed.If lot information does becomes available and if the record review indicates that there was a non-conformity a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

Event Description

As reported by a patient, after 12 years a codman 3000 pump is not working properly and the patient is experiencing withdrawal symptoms.Patient wants information concerning replacement.The doctor wrote in the notes the pump is nonfunctional.There is no plan to remove the pump at this time.The patient did present with some withdrawal symptoms and was given oral and transdermal medication which is being continued at this time.

• Brand Name: CODMAN 3000 PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 6842145
• MDR Text Key: 84721319
• Report Number: 1226348-2017-10660
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/17/2017
• Initial Date FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention